BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE W/QUICK-COUPLING

    MDR report key: 2883374 · Received December 21, 2012

    Report

    Report Number
    8030965-2012-01638
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    November 22, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION IS ON GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED AT SYNTHES (B)(4). THE INVESTIGATION SHOWED THAT THE SHAFT OF THE COUPLING IS BROKEN OFF. THE CAUSE IS NOT ABLE TO BE DETERMINED. IT MAY BE ASSUMED THAT THE INSTRUMENT HAS BEEN EXPOSED TO HIGH MECHANICAL FORCES. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THERE WAS A MATERIAL BREACH BETWEEN THE CLUTCH AND HANDLE. SUBSEQUENTLY, THE COUPLING BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDLE W/QUICK-COUPLING SCREW INSERTER OVE SYNTHES GMBH 1885799

    Patients

    Seq Age Sex Outcome Treatment
    1